An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC.
Public ClinicalTrials.gov record NCT05939414. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An International, Prospective, Open-label, Multi-center, Randomized Phase III Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) Versus Observation to Delay Castration or Disease Recurrence in Adult Male Patients With Prostate-specific Membrane Antigen (PSMA) Positive Oligometastatic Prostate Cancer (OMPC)
Study identification
- NCT ID
- NCT05939414
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Novartis Pharmaceuticals
- Industry
- Enrollment
- 450 participants
Conditions and interventions
Conditions
Interventions
- AAA617 Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 100 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 11, 2024
- Primary completion
- Apr 24, 2028
- Completion
- Oct 2, 2031
- Last update posted
- Apr 29, 2026
2024 – 2031
United States locations
- U.S. sites
- 38
- U.S. states
- 23
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Highlands Oncology Group | Fayetteville | Arkansas | 72703 | Recruiting |
| VA Greater LA Healthcare System | Los Angeles | California | 90073 | Recruiting |
| VA Palo Alto Health Care System | Palo Alto | California | 94304-1207 | Recruiting |
| Stanford University | Palo Alto | California | 94304 | Recruiting |
| UCSF | San Francisco | California | 94115 | Recruiting |
| Rocky Mountain Cancer Centers | Denver | Colorado | 80218 | Recruiting |
| Cancer Specialists of North Florida | Jacksonville | Florida | 32256 | Recruiting |
| Woodlands Medical Specialists | Pensacola | Florida | 32503 | Recruiting |
| Piedmont Healthcare | Atlanta | Georgia | 30318 | Recruiting |
| University of Chicago | Chicago | Illinois | 60637 | Recruiting |
| The Cancer Institute of Alexian Brothers | Elk Grove | Illinois | 60007 | Recruiting |
| Unity Point Clinic | Des Moines | Iowa | 50323 | Recruiting |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | Recruiting |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | 70809 | Recruiting |
| East Jefferson Hospital | Metairie | Louisiana | 70006 | Recruiting |
| University of Maryland Medical Ctr | Baltimore | Maryland | 21201 | Recruiting |
| Johns Hopkins Kimmel Com Cancer Ctr | Baltimore | Maryland | 21231 | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02115 | Recruiting |
| Beth Israel Deaconess Med Ctr | Boston | Massachusetts | 02215 | Recruiting |
| BAMF Health | Grand Rapids | Michigan | 49503 | Recruiting |
| Profound Research LLC | Royal Oak | Michigan | 48073 | Active, not recruiting |
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | Recruiting |
| VA St Louis Health Care System | St Louis | Missouri | 63106 | Recruiting |
| Wash U School of Medicine | St Louis | Missouri | 63110 | Recruiting |
| The Urology Center PC DBA UroHealth Partners | Omaha | Nebraska | 68114 | Recruiting |
| Memorial Sloan Kettering Cancer Ctr | New York | New York | 10065 | Recruiting |
| Associated Med Professionals of NY | Syracuse | New York | 13210 | Recruiting |
| Montefiore Hospital | The Bronx | New York | 10467 2490 | Recruiting |
| East Carolina University | Greenville | North Carolina | 27858 | Recruiting |
| Dayton Physicians | Kettering | Ohio | 45409 | Recruiting |
| Oregon Urology Institute | Springfield | Oregon | 97477 | Recruiting |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | Recruiting |
| Univ of Texas Southwest Med Center | Dallas | Texas | 75390-9034 | Recruiting |
| Rio Grande Urology | El Paso | Texas | 79912 | Recruiting |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | Recruiting |
| Blue Ridge Cancer Center | Wytheville | Virginia | 24382 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 104 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05939414, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2026 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05939414 live on ClinicalTrials.gov.